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510(k) K822392

MYOCUR BLADE PAC by Myocure, Inc. — Product Code HMN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 25, 1982
Date Received
August 9, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Suture, Nonabsorable, Ophthalmic
Device Class
Class III
Regulation Number
Review Panel
SU
Submission Type

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  • K874057 — OPHTHALMIC TIP & BLADE SCALPELS (December 23, 1987)
  • K874056 — OPHTHALMIC DISPOSABLE BLADES (December 22, 1987)
  • K873385 — OPHTHALMIC PHACO-BLADE (September 21, 1987)
  • K864371 — SURGICAL SKIN MARKER (November 17, 1986)
  • K863666 — THE SAVER KIT (October 20, 1986)
  • K863663 — OPHTHALMIC SURGICAL OCULAR MARKERS (October 20, 1986)
  • K863662 — OPHTHALMIC SURGICAL DRAPE (October 20, 1986)